E.W.L. P-TENS MODEL(TENS— 510(k) K813601

Name: FDA 510(k) clearance K813601
Creator: U.S. Food and Drug Administration
Published: 1982-03-19

Substantially Equivalent

Electronic Waveform Laboratory, Inc.

FDA 510(k) clearance K813601 for E.W.L. P-TENS MODEL(TENS, Substantially Equivalent on 1982-03-19. Applicant: Electronic Waveform Laboratory, Inc.. Device class: 2.

Clearance details

Applicant: Electronic Waveform Laboratory, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1981-12-28
Decision date: 1982-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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